JOCK ITCH- miconazole nitrate spray

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)
Available from:
Walgreen Company
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antifungal
Authorization status:
OTC monograph final
Authorization number:
0363-1497-90

JOCK ITCH- miconazole nitrate spray

Walgreen Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Walgreen Co. Jock Itch Powder Spray Drug Facts

Active ingredient

Miconazole nitrate 2%

Purpos e

Antifungal

Us es

Warnings

For external use only

Flammable: Do not use while smoking or near heat or flame

Do not use

on children under 2 years of age unless directed by a doctor

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

proven clinically effective in the treatment of most jock itch (tinea cruris)

for effective relief of itching, burning, scaling and discomfort, and chafing associated with jock

itch

avoid contact with the eyes

use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be

harmful or fatal.

contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F

(49°C).

irritation occurs

there is no improvement within 2 weeks

Other information

Inactive ingredients

alcohol denat., aluminum starch octenylsuccinate, isobutane, isopropyl myristate, propylene carbonate,

sorbitan monooleate, stearalkonium hectorite, talc

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Lotrimin® AF Powder Spray active ingredient

Jock Itch Powder Spray

MICONAZOLE NITRATE 2% / ANTIFUNGAL

GOES ON DRY

Clinically proven to cure most jock itch

Relieves itching, burning, scaling & chafing

NEW WT 4.6 OZ (130 g)

wash affected area and dry thoroughly

shake can well and spray a thin layer over affected area twice daily (morning and night)

supervise children in the use of this product

use daily for 2 weeks

if condition persists longer, ask a doctor

this product is not effective on the scalp or nails

in case of clogging, clean nozzle with a pin

store at 20-25°C (68-77°F)

JOCK ITCH

miconazole nitrate spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 36 3-149 7

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MICO NAZO LE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0 D7S5M)

MICONAZOLE NITRATE

2 g in 10 0 g

Walgreen Company

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

ALUMINUM STARCH O CTENYLSUCCINATE (UNII: I9 PJ0 O6 29 4)

ISO BUTANE (UNII: BXR49 TP6 11)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

PRO PYLENE CARBO NATE (UNII: 8 D0 8 K3S51E)

SO RBITAN MO NO O LEATE (UNII: 0 6 XEA2VD56 )

STEARALKO NIUM HECTO RITE (UNII: OLX6 9 8 AH5P)

TALC (UNII: 7SEV7J4R1U)

Product Characteristics

Color

WHITE (o ff-white)

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 36 3-149 7-

130 g in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

0 2/23/20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333C

0 2/23/20 18

Labeler -

Walgreen Company (008965063)

Revised: 10/2020

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